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Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor

CUDC-907 for Tumors

Q: Is geriatric participation being considered for this research project?

As per the prerequisites for enrolment, this clinical trial has a lower age limit of 1 year old and an upper age cap of 21.

Q: Are there any vacancies remaining in this clinical trial?

Affirmative. The details available on clinicaltrials.gov declare that this medical trial is currently recruiting participants, and the first posting was in October 1st 2016. 44 patients are needed from 4 different sites, with the information being most recently updated in August 13th 2022.

Q: How many healthcare facilities are administering this experiment?

Several medical centres are accepting patients for this research trial, such as Dana Farber Cancer Institute in Boston, Children's Hospital of Philadelphia in Philadelphia, and University of <a href="https://www.withpower.com/clinical-trials/california">California</a><a href="https://www.withpower.com/clinical-trials/cancer">r Canc</a>er Institute in Boston, Children's Hospital of Philadelphia in Philadelphia, and University of California at San Francisco Benioff Children's Hospital.

Q: Is this clinical investigation pioneering a new approach?

Since its inception in 2016, CUDC-907 has been subject to a plethora of studies. Initially sponsored by Curis, Inc., the first trial involving 44 participants ultimately led to Phase 1 drug approval. Currently, two trials are ongoing over 19 cities and 2 countries.

Q: Has the FDA sanctioned CUDC-907 for commercial use?

The safety of CUDC-907 was ranked a 1 due to the lack of data and clinical trials, signifying that it is in its initial stages.

Q: Could you outline the other investigations that have taken place with CUDC-907?

Presently, there are two trials for CUDC-907 in progress; neither of which currently occupy Phase 3. Baltimore serves as the hub for many of these investigations, though 24 other locations scattered throughout the US also administer clinical tests with this medication.

Q: How many individuals have registered to be part of this research?

In order to effectively conduct this trial, 44 eligible participants must be recruited. Curis, Inc., the sponsor of the study will manage it from locations such as Dana Farber Cancer Institute in <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a> and Children's Hospital of Philadelphia in <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a><a href="https://www.withpower.com/clinical-trials/cancer">ber Ca</a>ncer Institute in Massachusetts and Children's Hospital of Philadelphia in Pennsylvania.

Q: Is my eligibility criteria sufficient to become involved in this research?

This medical experiment is looking to enrol 44 individuals with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> between 1 and 21 years of age. In order for a patient to be eligible, they must possess either histologically confirmed solid tumors, CNS tumours or lymphoma that can be identified through biopsy/surgery at initial diagnosis or relapse/progression; the only exception being pediatric patients diagnosed exclusively by imaging criteria (diffuse intrinsic pontine gliomas and optic pathway gliomas). Furthermore, participants must have measurable disease in both parts A and B that has relapsed/refractory responses towards standard treatments.

Phase 1

Waitlist Available

Led By David S Shulman, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 1 years and ≤ 21 years at time of enrollment

Karnofsky performance status ≥ 50% for patients ≥16 years of age and Lansky ≥ 50% for patients <16 years of age

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up2 years

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing a new drug to see if it can help kids with solid tumors, lymphoma, or brain tumors that haven't responded to other treatments.

Eligible Conditions

Lymphoma
Neuroblastoma
Brain Tumor
Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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Participants must be between 1 and 21 years old when they join the study.

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You are able to perform daily activities at a certain level as determined by your doctor.

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Your disease must be able to be measured or evaluated.

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You have been diagnosed with solid tumors, brain tumors, or lymphoma based on a biopsy or surgery.

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You have a disease that has come back or is not responding to standard treatments.

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You must have a body size of at least 0.5 square meters.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity

Secondary outcome measures

Adverse Events per CTCAE Version 4

Duration of Response

Exposure (AUC) of CUDC-907 in Pediatrics

+3 more

Side effects data

From 2019 Phase 2 trial • 70 Patients • NCT02674750

72%

Diarrhea

54%

Hypokalemia

49%

Nausea

41%

Thrombocytopenia

40%

Hypomagnesia

35%

Fatigue

34%

Decreased appetite

28%

Vomiting

28%

Dehydration

26%

Anemia

26%

Dyspnea

21%

Constipation

21%

Arthralgia

21%

Neutropenia

19%

Pyrexia

19%

Pain in extremity

19%

Hyperuricemia

19%

Dizziness

18%

Abdominal Pain

18%

Hypocalcemia

16%

Back pain

16%

Acute Kidney Injury

13%

Cough

12%

Peripheral edema

10%

Diffuse Large B Cell lymphoma

Upper Respiratory Infection

Oropharyngeal Pain

Musculoskeletal pain

Headache

Atrial fibrillation

Asthensia

Dysgeusia

Pruritus

Insomnia

Dyspepsia

Chills

Sepsis

Diarhhea

Lymphoma

Abdominal Pain Upper

Asthenia

Disease Progression

Non-cardiac chest pain

Cytomegalovirus

Enterococcal

Pneumonia

Febrile Neutropenia

Cholecystitis

hyperbilirubenemia

COPD

Pulmonary Embolism

Gullain-Barre Syndrome

Device occulsion

Small Intestinal Obstruction

Citrobacter Batremia

Wound infection

Tracheal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

CUDC-907

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CUDC-907Experimental Treatment1 Intervention

CUDC-907 orally administered CUDC-907 once daily for 5 consecutive days per week followed by two days without dosing Dose level assigned at registration Pre-dose pharmacokinetic blood sample will be collected Dose escalation will follow a standard 3+3 design

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CUDC-907

2016

Completed Phase 2

~120

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,058 Previous Clinical Trials

338,973 Total Patients Enrolled

59 Trials studying Lymphoma

2,385 Patients Enrolled for Lymphoma

Curis, Inc.Industry Sponsor

16 Previous Clinical Trials

1,088 Total Patients Enrolled

5 Trials studying Lymphoma

350 Patients Enrolled for Lymphoma

David S Shulman, MD5.01 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

2 Previous Clinical Trials

361 Total Patients Enrolled

1 Trials studying Lymphoma

21 Patients Enrolled for Lymphoma

Media Library

CUDC-907 (Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02909777 — Phase 1

Lymphoma Research Study Groups: CUDC-907

Lymphoma Clinical Trial 2023: CUDC-907 Highlights & Side Effects. Trial Name: NCT02909777 — Phase 1

CUDC-907 (Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02909777 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation being considered for this research project?

"As per the prerequisites for enrolment, this clinical trial has a lower age limit of 1 year old and an upper age cap of 21."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Affirmative. The details available on clinicaltrials.gov declare that this medical trial is currently recruiting participants, and the first posting was in October 1st 2016. 44 patients are needed from 4 different sites, with the information being most recently updated in August 13th 2022."

Answered by AI

How many healthcare facilities are administering this experiment?

"Several medical centres are accepting patients for this research trial, such as Dana Farber Cancer Institute in Boston, Children's Hospital of Philadelphia in Philadelphia, and University of California r Cancer Institute in Boston, Children's Hospital of Philadelphia in Philadelphia, and University of California at San Francisco Benioff Children's Hospital."

Answered by AI

Is this clinical investigation pioneering a new approach?

"Since its inception in 2016, CUDC-907 has been subject to a plethora of studies. Initially sponsored by Curis, Inc., the first trial involving 44 participants ultimately led to Phase 1 drug approval. Currently, two trials are ongoing over 19 cities and 2 countries."

Answered by AI

Has the FDA sanctioned CUDC-907 for commercial use?

"The safety of CUDC-907 was ranked a 1 due to the lack of data and clinical trials, signifying that it is in its initial stages."

Answered by AI

Could you outline the other investigations that have taken place with CUDC-907?

"Presently, there are two trials for CUDC-907 in progress; neither of which currently occupy Phase 3. Baltimore serves as the hub for many of these investigations, though 24 other locations scattered throughout the US also administer clinical tests with this medication."

Answered by AI

How many individuals have registered to be part of this research?

"In order to effectively conduct this trial, 44 eligible participants must be recruited. Curis, Inc., the sponsor of the study will manage it from locations such as Dana Farber Cancer Institute in Massachusetts and Children's Hospital of Philadelphia in Pennsylvania ber Cancer Institute in Massachusetts and Children's Hospital of Philadelphia in Pennsylvania."

Answered by AI

Is my eligibility criteria sufficient to become involved in this research?

"This medical experiment is looking to enrol 44 individuals with lymphoma between 1 and 21 years of age. In order for a patient to be eligible, they must possess either histologically confirmed solid tumors, CNS tumours or lymphoma that can be identified through biopsy/surgery at initial diagnosis or relapse/progression; the only exception being pediatric patients diagnosed exclusively by imaging criteria (diffuse intrinsic pontine gliomas and optic pathway gliomas). Furthermore, participants must have measurable disease in both parts A and B that has relapsed/refractory responses towards standard treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma

David S Shulman, MD 2016. "Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02909777.

All > Lymphoma > Neuroblastoma